File No.297/APPCB/CFE/RO-VSP/HO/2014

ANDHRA PRADESH POLLUTION CONTROL BOARD D. No. 33-26-14 D/2, Near Sunrise Hospital, Pushpa Hotel Centre, Chalamalavari Street, Kasturibaipet, Vijayawada - 520 010 Website: www.pcb.ap.gov.in

CONSENT ORDER FOR ESTABLISHMENT

Order No. 297 /APPCB/CFE/RO-VSP/HO/2014 17/07/2020

Sub: APPCB – CFE - M/s. Granules Omni Chem Pvt. Ltd., Plot No. 121 (P) & 122, JNPC, Parawada, District – Consent for Establishment of the Board for Change of Product Mix under Sec. 25/26 of Water (P & C of P) Act, 1974 and under Sec. 21 of Air (P&C of P) Act, 1981 - Issued - Reg.

Ref: 1. EC Order dt: 10.03.2005 for the entire JNPC Parawada. 2. CFE Order dt. 30.11.2019. 3. Industry’s application received through APOCMMS on 25.06.2020. 4. R.O’s inspection report dt. 06.07.2020. 5. CFE Committee meeting held on 07.07.2020.

1. In the reference 3rd cited, an application was submitted to the Board seeking Consent for Establishment (CFE) for Change of Product Mix within the existing premises to produce the products with installed capacities as mentioned below, with additional project cost of Rs.5 Lakhs.

As per CFE order dt.30.11.2019:

S. Quantity Name of the Products and By-products No (Kg/Day) 1. Valsartan 1.67 2. Metformin HCL 333.33 3. N-Boc – L – Pyroglutamic Acid ethyl ester (PAC-2) 33.33 8-Benzyl-3-(3-isopropyl-5-methyl-4H-1,2,4-triazol-4- yl)-8- 4. 50.00 azabicyclo[3.2.1]octane (BTC7) 5. Formyltosylamide (FTA-1) 166.67 4-methoxy-1-(phenylsulfonyl)-2,3-dihydro-1Hpyrrolo[2,3- 6. 36.67 c]pyridine (BES 6) 7-Bromo-4-methoxy-1H-pyrrolo[2,3-c]pyridine. 7. 30.00 Hydrochloride (BES-10) 2,3,4,6-Tetra-Opivaloyl-D-glucopyranosyl-bromide (FBJ- 2)** 8. 2,3,4,6 - Tetra -O- pivaloyl-Dglucopyranosylbromide (GLU- 233.33 2)** File No.297/APPCB/CFE/RO-VSP/HO/2014

Tert-butyl (2S, 3R)-3-hydroxy-4-(isobutylamino)-1- 9. phenylbutan-2-yl carbamate (BIN-1) 166.67

2-Piperidinecarboxylic acid, 5- [(phenylmethoxy)amino]-, 10. 200.00 phenylmethyl ester, (2S,5R)- (ethanedioate)(SAM-0) Tetrabutylammonium [(2S,5R)-2-Carbamoyl-7-oxo-1,6- 11. 200.00 diazabicyclo[3.2.1]octan-6-yl] Sulfate(SAM-3) (2R,5S)-((1R,2S,5R)-2-isopropyl-5-methyl cyclohexyl) 5- 12. (4-amino-2-oxopyrimidin-1(2H)-yl)-1,3-oxathiolane-2- 33.33 carboxylate (LAM-5) (R)-2-((4-aminopiperidin-1-yl)methyl)-1,2-dihydro3H,8H- 13. 2a,5,8a-triazaacenaphthylene-3,8-dione 80.00 hemihydrochloride (GPO-3) Sodium(3,4-dihydro-2H-pyrano[2,3-c] pyridin-6- yl) 14. 50.00 (hydroxyl) methane sulfonate (GPO-4) (7-bromo-4-methoxy-1H-pyrrolo[2,3-c] pyridin-3- yl) 15. 18.33 (oxo)acetic acid (BES-12) (2S)-2-(hydroxymethyl)-1,2-dihydro-3H,8H-2a,5, 8a- 16. 37.27 triazaacenaphthylene-3,8-dione (GPA-807A) Methyl 3,4-Dihydro-2H-Pyrano[2,3-C]Pyridine-6- 17. 15.33 Carboxylate (GPE) 18. Quetiapine Lactam (SER-2) 11.67 Total 1300.00*

* The industry shall manufacture any 6 products including API & Drug Intermediates at any point of time so that the maximum production shall not exceed 1300 Kg/day. ** Either FBJ-2 or GLU-2 will be manufactured at any given point of time.

After Change of Product Mix:

S. Name of the Prod Quantity No of Starting Raw Mat Quantity of No. ucts (TPM) Stages erial Starting R aw Materia l (TPM) (S)-Methyl N-[(2 cyanobiphenyl- 1. Valsartan 16.67 1 4-yl)methyl]-L-V 27.80 alinate Hydrochl oride (vsv) Dimethylamino Hy 2. Metformin HCL 533.33 1 307.60 drochloride 8-Benzyl-3-(3-isopr opyl-5-methyl-4H-1 2,5-dimethoxy THF 3. ,2,4-triazol-4- yl)-8- 33.33 2 45.00 (DMTHF) azabicyclo[3.2.1]oc tane (BTC7) File No.297/APPCB/CFE/RO-VSP/HO/2014

Formyltosylamide ( 83.33 1 4-methyl benze 73.30 4. FTA-1) ne sulfonamide 4-methoxy-1-(phen ylsulfonyl)-2,3-dihy Formyltosylami 5. 36.67 4 56.70 dro-1Hpyrrolo[2,3-c de (FTA-1) ]pyridine (BES 6) 4-methoxy-1-(p 7-Bromo-4-methox henylsulfonyl)-2 y-1H-pyrrolo[2,3-c] 6. 30.00 1 -3-dihydro-1H-p 46.20 pyridine. Hydrochlo yrrolo[2,3-c]pyri ride (BES-10) dine (BES-6) 2,3,4,6-Tetra-Opival oyl-D-glucopyranos D-Glucose 67.00 yl-bromide (FBJ-2)** or 7. 166.67 1 2,3,4,6 - Tetra -O- pi valoyl-Dglucopyran D-Glucose 69.00 osylbromide (GLU-2 )** Tert-butyl (2S, 3R)- 3-hydroxy-4-(isobut 8. ylamino)-1- phenylb 166.67 1 S,S-BEP-3 185.60 utan-2-yl carbamat e (BIN-1) (2R,5S)-((1R,2S,5R)- 2-isopropyl-5-methy l cyclohexyl) 5- (4-a Methylglyoxylat 9. mino-2-oxopyrimidi 66.67 1 66.67 e (MGH) n-1(2H)-yl)-1,3-oxat hiolane-2- carboxyl ate (LAM-5) (R)-2-((4-aminopipe (2S)-2-(hydroxy ridin-1-yl)methyl)-1, methyl)-1,2-dihy 2-dihydro3H,8H- 2a, dro-3H,8H-2a,5, 10. 5,8a-triazaacenapht 50.00 2 71.5 8a-triazaacenap hylene-3,8-dione he hthylene-3,8-dio mihydrochloride (G ne (GPA-807A) PO-3) Sodium(3,4-dihydro Methyl 3,4-Dihy -2H-pyrano[2,3-c] p dro-2H-Pyrano[2 11. yridin-6- yl)(hydrox 50.00 1 ,3-C]Pyridine-6- 43.00 yl) methane sulfona Carboxylate (GP te (GPO-4) E) (7-bromo-4-methox 7-Bromo-4-methox y-1H-pyrrolo[2,3-c] y-1H-pyrrolo[2,3-c] 12. 26.67 1 27.00 pyridin-3- yl)(oxo)ac pyridine. Hydrochlo etic acid (BES-12) ride (BES-10) File No.297/APPCB/CFE/RO-VSP/HO/2014

(2S)-2-(hydroxymet hyl)-1,2-dihydro-3H, 8H-2a,5, 8a- 2-Chloro-6-methox 13. 50.00 4 148.00 triazaacenaphthyle y-3-nitropyridine ne-3,8-dione (GPA-8 07A) Methyl 3,4-Dihydro- 2H-Pyrano[2,3-C]Py 14. 50.00 2 Glycine 96.00 ridine-6- Carboxylat e (GPE) Quetiapine Lactam 2-Amino-diphen 15. 133.33 2 135.00 (SER-2) ylsulfide 1300 kg/ Total day

The industry shall manufacture any 9 products including API & Drug Intermediates at point of time so that the maximum production shall not exceed 1300 Kg/day.

Either FBJ-2 or GLU-2 will be manufactured at any given point of time.

By-Products:

S. No. Name of By-products Quantity (TPD) 1. Palladium Carbon 3.68

2. As per the application, the above activity is to be located within the existing industry premises located at Plot No.121/P & 122, JNPC, Parawada, Visakhapatnam in an area of 12.135 acres.

3. The industry was inspected by the Environmental Engineer, Regional Office, Visakhapatnam, A.P Pollution Control Board on 04.07.2020 and observed that the site is surrounded by

North : Plot No : 120 & Part of Plot No:121 South : 30 M wide SEZ internal road followed by hills. East : Road followed by APEPDCL substation & Ramky Green belt. West : M/s Eisai Pharma Ltd.

4. The Board, after careful scrutiny of the application, verification report of the Regional Officer and recommendation of the CFE committee hereby issues CONSENT FOR ESTABLISHMENT FOR CHANGE OF PRODUCT MIX to the project under Section 25/26 of Water (Prevention & Control of Pollution) Act 1974 and Section 21 of Air (Prevention & Control of Pollution) Act, 1981 and the rules made there under. This order is issued to manufacture the products as mentioned at para (1) only.

File No.297/APPCB/CFE/RO-VSP/HO/2014

5. This Consent order now issued is subject to the conditions mentioned in the Annexure.

6. This order is issued from pollution control point of view only. Zoning and other regulations are not considered.

7. This order is valid for a period of 7 years.

Encl: Annexure.

BATCHU SIVA PRASAD, JCEE(BSP), O/o JOINT CHIEF ENVIRONMENTAL ENGINEER1-APPCB JOINT CHIEF ENVIRONMENTAL ENGINEER

To

M/s. Granules Omnichem Pvt., Ltd., (CPM) Plot No.121/P & 122, JNPC, Parawada, Visakhapatnam. [email protected] [email protected]

Copy to: 1.The JCEE, Z.O: Visakhapatnam for information and necessary action. 2. The E.E., R.O: Visakhapatnam for information and necessary action.

ANNEXURE

1. The applicant shall provide separate energy meters for Effluent Treatment Pla nt (ETP) and Air pollution Control equipments to record energy consumed. An a lternative electric power source sufficient to operate all pollution control syste ms shall be provided.

2. The industry shall construct separate storm water drains and provide rain wate r harvesting structures. No effluents shall be discharged in to the storm water drains.

Water:

3. The source of water is JNPC, Parawada and the maximum permitted water cons umption after Change of Product Mix is as following:

After Change of Product Mix:

File No.297/APPCB/CFE/RO-VSP/HO/2014

S. No. Purpose Quantity as per Quantity after CPM CFE order dated (KLD) 30.11.2019 (KLD) 1. Process 2. Washings 140.70 148.80 3. RO rejects 4. Boiler 100.00 100.00 5. Cooling Towers 6. Domestic 40.00 40.00 7. Gardening 120.00 120.00 Total 400.70 408.80 KLD

Separate meters with necessary pipe-line shall be provided for assessing the quantity of water used for each of the purposes mentioned above.

4. The maximum waste water generation shall not exceed the following:

S. Source Quantity as per CFE Quantity after CPM No. order dated 30.11.2019 (KLD) (KLD) HTDS LTDS TOTAL HTDS LTDS TOTAL 1. Process 29.74 - 29.74 36.24 - 36.24 2. Washings - 10.00 10.00 - 10.00 10.00 3. Boiler - 2.00 2.00 - 2.00 2.00 Cooling 4. - 5.00 5.00 - 5.00 5.00 Towers DM Plant 5. - 15.00 15.00 - 15.00 15.00 regeneration, 6. RO plant Rejects.& Back - 44.80 44.80 - 44.80 44.80 washes 7. Scrubber 5.00 - 5.00 5.oo - 5.00 8. Domestic - 32.00 32.00 - 32.00 32.00 Total 34.74 108.80 143.54 41.24 108.80 150.04 Treatment & disposal:

Source Treatment Mode of final disposal HTDS Pretreatment To M/s. Ramky Pharmacity for forced (Neutralization) evaporation. 60 KL – 4 Nos

LTDS Pretreatment To CETP of M/s. Ramky Pharmacity for (Neutralization) further treatment and disposal

180 KL - 4 Nos.

File No.297/APPCB/CFE/RO-VSP/HO/2014

Domestic --- The overflow of the Septic tank shall be sent waste water to the CETP for further treatment.

5. Effluents shall not be discharged on land or into any water bodies or aquifers u nder any circumstances.

6. The industry shall properly operate and maintain online real time monitoring s ystem along with web camera facilities and shall ensure that it is connected to APPCB / CPCB websites as per CPCB directions.

7. Floor washing shall be admitted into the effluent collection system only and sh all not be allowed to find their way in storm drains or open areas. All pipe valv es, sewers, drains shall be leak proof.

Air:

8. The Air pollution Control equipment shall be maintained properly to comply wit h the following for controlling air pollution after Change of Product Mix:

S. Details of Stack Stack – I Stack – II Stack –III

No a) Attached to: Boiler D.G Set D.G Set b) Capacity 1 x 6 TPH 1 x 1500 KVA 1 x 1450 KVA c) Fuel form : Coal Diesel Diesel d) Stack height: 40 m 8 m above roof 8 m above level roof level e) Details of Air Pollution Cyclone separator Acoustic Acoustic Control Equipment: & Bag Filter Enclosures & Enclosures & silencer silencer

9. A sampling port with removable dummy of not less than 15 cm diameter shall be provided in the stack at a distance of 8 times the diameter of the stack fro m the nearest constraint such as bends etc. A platform with suitable ladder sh all be provided below 1 meter of sampling port to accommodate three persons with instruments. A 15 AMP 250 V plug point shall be provided on the platform.

10. The industry shall properly operate and maintain the monitoring system to all t he stacks / vents in the plant. Regular monitoring shall be carried out and repo rt shall be submitted to the Regional officer.

File No.297/APPCB/CFE/RO-VSP/HO/2014

11. The industry shall properly operate and maintain multi-stage scrubbers to the process vents to control the process emissions. The industry shall ensure that online pH measuring facility with auto recording system is connected to the sc rubbers.

The emissions containing Bromine gases shall be routed through water scrubb er, caustic scrubber provided in series. The vent of the caustic scrubber shall b e dipped into dilute caustic soda lye for effective removal of Bromine in the em issions. Two stage Caustic scrubbers shall be provided to control acid emission s.

12. The industry shall properly operate and maintain VOC monitoring system with auto recording facility.

13. The industry shall implement adequate measures to control all fugitive emissio ns from the plant.

14. The proponent shall ensure compliance of the National Ambient Air quality sta ndards notified by MoEF, GoI vide notification No. GSR. 826 (E), dated. 16.11.2 009 during construction and regular operational phase of the project at the per iphery.

The generator shall be installed in a closed area with a silencer and suitable no ise absorption systems. The ambient noise level shall not exceed 75 dB(A) dur ing day time and 70 dB(A) during night time.

15. The proponent shall not use or generate odour causing substances or Mercapt ans and cause odour nuisance in the surroundings.

16. The industry shall send the used / spent solvents to the recyclers (or) process t hem at their own solvent recovery facility within the premises.

17. The evaporation losses in solvents shall be controlled by taking the following measures:

i. Chilled brine circulation shall be carried out to effectively reduce the solv ent losses into the atmosphere. ii. Transfer of solvents shall be done by using pumps instead of manual han dling. iii. Closed centrifuges shall be used to reduce solvent losses. iv. All the solvent storage tanks shall be connected with vent condensers to prevent solvent vapours. v. The reactor vents shall be connected with primary & secondary condense rs to prevent escaping of solvent vapour emissions into atmosphere.

File No.297/APPCB/CFE/RO-VSP/HO/2014

Solid / Hazardous Waste:

18. The industry shall comply with the following for disposal of Solid waste:

S. No Name of the Quantity a Total after Mode of Disposal . waste s per CFE CPM Order dt:3 0.11.2019 1. Organic Solid 1077.49 1350.94 To authorized cement industries Waste (kg/day for Co-processing or TSDF para ) wada Visakhapatnam for Inciner ation 2. Inorganic Solid 419.74 3033.09 To TSDF parawada for secured l Waste (from Pr and filling or Authorized cement ocess) (kg/day industries for Co-processing. ) 3. Spent Carbon 8.33 83.33 To TSDF parawada for secured l (kg/day) and filling or Authorized cement industries for Co-processing.

4. ETP Sludge (kg 100.00 100.00 To TSDF parawada for secured l /day) and filling or Authorized cement industries for Co-processing.

5. Time expired / 50.00 50.00 To TSDF parawada for secured l reject Raw ma and filling or Authorized cement terials (kg/day industries for Co-processing. ) 6. Off Specificatio 50.00 50.00 n & Discarded Products (kg/d ay) 7. Insulation Was 10.00 10.00 To TSDF Parawada for secured l te (kg/day) and filling / Incineration. 8. Used PPE 10.00 10.00 9. Used filter Bag 20.00 20.00 s & Filters (kg/ day) 10. Containers & C 800 Nos./m 800 Nos./ m After detoxification, it shall be d ontainer liners onth onth isposed to the outside agencies. of Hazardous c hemicals 11. Waste Oils & G 800 LPA 800 LPA Authorized Reprocesses / Recyc rease lers 12. Spent Solvents 160 TPM 220 TPM Shall be recovered within the pr emises / disposed to PCB autho rized recycling units. 13. Coal Ash 2.3 TPD 2.3 TPD Brick Manufacturing units

File No.297/APPCB/CFE/RO-VSP/HO/2014

19. The proponent shall place the chemical drums and / or any drums in a shed provided with concrete platform only. The Platform shall be provided with sufficient dyke wall and effluent collection system. The industry shall provide containers detoxification facility. Container & Container liners shall be detoxified at the specified covered platform with dyke walls and the wash wastewater shall be routed to low TDS collection tank.

20. The following rules and regulations notified by the MoEF&CC, GoI shall be implemented.

a) Regulation of Persistent Organic Pollutants Rules, 2018. b) Hazardous waste and other wastes (Management and Transboundary Movement) Rules, 2016. c) Plastic Waste Management Rules, 2016. d) Manufacture, Storage and Import of Hazardous Chemicals Rules, 1989 e) Fly Ash Notification, 2016. f) Batteries (Management & Handling) Rules, 2010. g) E-Waste (Management) Rules, 2016. h) Construction and Demolition waste Management Rules, 2016. i) Solid Waste Management Rules, 2016. j) The Public Liability Insurance Act, 1991 and its amendments thereof.

Other Conditions:

21. The industry shall connect VOC absorption media to vent condenser within 2 months. 22. The industry shall install online analyzer for TOC at the vent out let within 3 months 23. The industry shall update the safety audit report and submit the same at the Regional office. 24. The industry shall validate PLI policy and submit the same at the Regional office. 25. Existing green belt shall not be disturbed due to the proposed expansion. Thick green belt shall be maintained all along the boundary & vacant spaces with tall growing trees with good canopy and it shall not be less than 33% of the total area.

26. The industry shall submit the information regarding usage of Ozone Depleting Substance once in six months to the Regional Office and Zonal Office of the Board.

File No.297/APPCB/CFE/RO-VSP/HO/2014

27. Concealing the factual data or submission of false information / fabricated data and failure to comply with any of the conditions mentioned in this order attracts action under the provisions of relevant pollution control Acts.

28. Notwithstanding anything contained in this conditional letter or consent, the Board hereby reserves its right and power Under Sec. 27(2) of Water (Prevention and Control of Pollution) Act, 1974 and Under Sec.21(4) of Air (Prevention and Control of Pollution) Act, 1981 to revoke the order, to review any or all the conditions imposed herein and to make such modifications as deemed fit and stipulate any additional conditions.

29. Any person aggrieved by an order made by the State Board under Section 25, Section 26, Section 27 of Water Act, 1974 or Section 21 of Air Act, 1981 may within thirty days from the date on which the order is communicated to him, prefer an appeal as per Water Rules, 1976 and Air Rules,1982, to such authority (hereinafter referred to as the Appellate Authority) constituted under Section 28 of Water (Prevention and Control of Pollution)Act,1974 and Section 31 of the Air (Prevention and Control of Pollution) Act, 1981.

BATCHU SIVA PRASAD, JCEE(BSP), O/o JOINT CHIEF ENVIRONMENTAL ENGINEER1-APPCB JOINT CHIEF ENVIRONMENTAL ENGINEER

To

M/s. Granules Omnichem Pvt., Ltd., (CPM) Plot No.121/P & 122, JNPC, Parawada, Visakhapatnam. [email protected] [email protected]